TurboAC™ Risk Management: All in One Global Risk Management Solutions

- All in one Electronic Risk Management File in compliance with standards and regulations (e.g. ISO 14971, ISO 13485 and FDA requirements)

- Support  multiple risks (safety, performance, cybersecurity, business etc.) and multiple sets (for different business units, product lines etc.)

- Highly configurable Templates for Hazard Analysis / Risk Assessment, Failure Mode and Effects Analysis (dFMEA, uFMEA and pFMEA) with results automatically linked

- Built-in toolkit for Fault Tree Analysis (FTA) with reliability calculation and automatic linking with the risk analysis results

- Multi Analytical Reports - Risk Heat Map, Interaction Maps, Checklists etc.

- Part 11 Compliant Electronic records and signatures

- Plug ins and APIs for connectivity with other requirement management tools 

TurboAC™ Assurance Cases:  All in One Assurance Case Development Solutions

 

- Tabular, graphic, and narractive safety assurance case editors

​- Able to convert the tabular or XML format safety assurance case into graphic HTML file that can be viewed and navigated using a web browser

​- Able to convert existing risk management information into a safety assurance case table or graphic

​- Integration of risk management and safety assurance case throughout the product life cycle

​- Intuitively guiding for additional information that is needed for a robust safety assurance case

​- Electronic submission of safety assurance cases to the FDA

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TurboAC™ Design Controls: All in One Solutions for Design Controls

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- Intuitive traceability among needs, requirements, specifications, test cases results 

- Tabular, graphic and narrative editors, and Export to html, word or PDF

- Automatic linking to TurboAC risk management and safety assurance cases 

- Design History File (DHF) Management (Plans, Reports etc.)

- Life cycle change management

TurboAC™ Cybersecurity: All in One Solutions for Cybersecurity Risk Management

- All in one Electronic Cybersecurity Risk Management File in compliance with standards and regulations

- Highly configurable Templates for Asset Profiling, Threat Modeling / Attack Tree Analysis, Vulnerability Analysis, Security Control Measures, Cybersecurity Risk Assessment and Summary etc.

- Automatic connectivity with Safety Risk Management

- Multi Analytical Reports - Risk Heat Map, Standard based Checklists etc.

- Part 11 Compliant Electronic records and signatures

- Life Cycle Cybersecurity Risk Management